a study of cm326 in patients with chronic rhinosinusitis with nasal polyps

Conditions: Chronic Rhinosinusitis With Nasal Polyps

Summary: this is a multi-center, randomized, double blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, pk, pd, immunogenicity and preliminary efficacy of cm326 in patients with chronic rhinosinusitis with nasal polyps.

the study consists of 3 periods, a screening period, a treatment period and a safety follow-up period. subjects who meet eligibility criteria will be randomized to receive either cm326 or placebo subcutaneously.

Eligibility criteria:
inclusion criteria: * subjects who are capable of understanding the nature of the study and voluntarily signing the icf. * male or female subjects, aged between 18 and 70 years old (inclusive), with a body mass index (bmi) ≥ 19 kg/m2. * diagnosed with chronic rhinosinusitis with nasal polyps. * the total nps score should be at least 3 points, with at least 1 point in each side of the nasal cavity. * prior treatment with systemic corticosteroids (scs) within two years before screening, and/or contraindicate to or intolerance to systemic corticosteroids, and/or with prior surgery to nasal polyps 6 months before the screening. * ongoing symptoms for at least 4 weeks before screening：1) nasal congestion/obstruction; 2) other symptom, e.g., loss of smell or rhinorrhea. exclusion criteria: * allergic or intolerant to mometasone furoate spray or cm326/placebo. * have used of systemic immunosuppressants for inflammatory or autoimmune diseases within 8 weeks or 5 half-lives prior to randomization. * have initiated leukotriene receptor antagonist therapy within 4 weeks prior to randomization. * have received allergen-specific immunotherapy that initiated within 3 months prior to randomization or planned to be initiated during the study period. * have undergone nasal surgery (including nasal polypectomy) within 6 months prior to screening. * have received medium- and short-acting systemic corticosteroids (including oral, intravenous, intramuscular corticosteroids), nasal dripping corticosteroids, traditional chinese medicine (including systemic and local herbal products preparations) for chronic rhinosinusitis (crs) within 4 weeks prior to screening, or long-acting systemic corticosteroids. * with concomitant asthma (including suspected diagnosis of asthma) will be excluded if they meet the following conditions: predicted fev1 of≤ 60%, or acute exacerbation of asthma within 3 months prior to screening requiring scs or hospitalization (\> 24 hours), or using inhaled corticosteroids (ics) of \> 1000 μg fluticasone propionate or others at equivalent doses * with antrochoanal polyps. * with severe deviation of the nasal septum occludes at least one nostril. * with persistent rhinitis medicamentosas. * with allergic granulomatous angiitis (churg-strauss syndrome), granulomatosis with polyangiitis (wegener's granulomatosis), young's syndrome, kartagener's syndrome or other dyskinetic ciliary syndromes, cystic fibrosis. * with acute sinusitis, nasal infection, or upper respiratory tract infection at screening. * have symptoms or whose ct scan suggests allergic fungal sinusitis. * with malignant or benign neoplasm of nasal cavities. * with other uncontrolled serious diseases or recurrent chronic diseases. * have severe hepatic and renal impairment. * have received live attenuated vaccines within 12 weeks prior to randomization, or during the planned study; or have received inactivated vaccines (e.g., novel coronavirus vaccines) within 30 days prior to randomization. * with known or suspected immunosuppression, including, but not limited to, the history of invasive opportunistic infections. * subjects who are pregnant or planning to become pregnant, or breastfeeding during the study. * with a history of large alcohol consumption or a history of drug abuse within 3 months prior to screening. * with other medical or non-medical conditions that are not suitable for participation in the study in the opinion of the investigator.